Evolus reports positive Phase III data of prabotulinumtoxinA

20th February 2018 (Last Updated February 20th, 2018 00:00)

Evolus has reported positive data from a Phase III clinical trial evaluating prabotulinumtoxinA in comparison with onabotulinumtoxinA for the treatment of patients with glabellar lines, also known as ‘frown lines’ between the eyebrows.

Evolus has reported positive data from a Phase III clinical trial evaluating prabotulinumtoxinA in comparison with onabotulinumtoxinA for the treatment of patients with glabellar lines, also known as ‘frown lines’ between the eyebrows.

EVB-003 is a 150-day, multicentre, randomised, double-blind, active and placebo-controlled, single-dose non-inferiority study.

Approximately 540 adults aged 18 or older were enrolled with moderate to severe glabellar lines at maximum frown, as assessed by the investigator on the four-point glabellar line scale.

Enrolled subjects stated that they felt their glabellar lines had an important psychological impact.

As part of the trial, patients were randomised at 5:5:1 ratio to receive a single treatment of 20 U prabotulinumtoxinA, 20 U onabotulinumtoxinA or placebo.

The primary efficacy objective of the EVB-003 trial was measured on day 30 and a responder was defined as a GLS score of zero or one at maximum frown following evaluation by the trial investigator.

"The trial met its primary endpoint of non-inferiority at day 30, with responder rates of 87.2% in the prabotulinumtoxinA group, 82.8% in the onabotulinumtoxinA group, and 4.2% for placebo."

From the total enrolled patients, 245 received prabotulinumtoxinA, 246 had onabotulinumtoxinA, while 49 were given placebo.

According to Evolus, the trial met its primary endpoint of non-inferiority at day 30, with responder rates of 87.2% in the prabotulinumtoxinA group, 82.8% in the onabotulinumtoxinA group, and 4.2% for placebo.

The trial reported 15.5% drug-related adverse events in prabotulinumtoxinA group, as well as 14.6% and 4.1% similar events in the onabotulinumtoxinA and placebo groups respectively. No serious adverse events were reported that were examined as study-drug related.

PrabotulinumtoxinA is a 900 kilodalton (kDa) purified botulinum toxin type A complex and its biologics licence application (BLA) is currently under review of the US Food and Drug Administration (FDA).

OnabotulinumtoxinA is also a 900 kDa botulinum toxin type A complex.